IT QA Lead | Cell and Gene Therapy

Greater Boston, MA

Posted: 10/26/2020

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SQA Group is a technology and advisory services firm in growth mode, partnering with Fortune 500 companies, large enterprises and mid-market organizations to help our clients craft a culture of continuous transformation. We introduce a blend of emerging technology solutions, data science services, and consulting services to fuel our clients’ modernization initiatives. We help them accelerate to next.

Are you an IT Quality thought leader looking for an opportunity to work on Cell and Gene therapy Manufacturing Systems in a fast paced environment bringing unique therapies to market?

SQA is working with a leading pharmaceutical company who needs additional bandwidth in their IT QA team located in greater Boston, MA. We are looking for an IT QA resource to support their GMP, GDP and GVP systems.

This position will be responsible for supporting the Computerized Systems Quality and Management (CSQM) group working closely with the operational functions and other QA groups to provide oversight of GxP computerized system implementation, maintenance, and retirement. This role will review and approve computerized system lifecycle documentation as well as provide GAMP, Part 11/ Annex 11, and data integrity expertise to key stakeholders.

 

What You’ll Do:

  • Develop an understanding of regulations pertaining to the implementation and use of computerized systems in GCP / GMP areas
  • Participate in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk based approach based on GAMP 5
  • Review and approve system lifecycle deliverables for new and modifications to existing computerized systems used in the GCP / GMP areas
  • Consult with CSQM team members and relevant internal stakeholders to identify / define high risk areas with the intent on focusing on patient safety, product quality and data integrity
  • Identify and escalate areas of risk or non-compliance to manager/leadership team
  • Participate in performing Periodic Review activities of Computerized Systems
  • Provide support to regulatory inspection preparedness activities as needed
  • Experience performing Infrastructure Qualification activities

 

What You Bring:

  • Strong knowledge in Cell and Gene therapy development and manufacturing systems; PLC, Automation, LIMS, PAT
  • Performing Quality Assurance function related to Computerized Systems / Infrastructure
  • Proficiency with regulations related to FDA / MHRA regulations
  • Use of computerized quality management systems
  • Experience with validation of Enterprise / Lab Computerized Systems
  • Quality metrics, dashboards, analysis and improvement programs
  • Knowledge of GAMP and Agile validation lifecycle and methodologies

 

This is a Consulting position

Job ID: 2010-5936

Thank you for your interest in pursuing a career at SQA Group! SQA Group is an equal opportunity employer and supports workforce diversity. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities above are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.

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